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Diss Factsheets
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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 19 February to 05 March 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- June 26, 2020
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N,N,N-trimethyl-3-{[(2E)-3-phenylprop-2-enoyl]amino}propan-1-aminium chloride
- Molecular formula:
- C15H23ClN2O
- IUPAC Name:
- N,N,N-trimethyl-3-{[(2E)-3-phenylprop-2-enoyl]amino}propan-1-aminium chloride
- Test material form:
- liquid: viscous
- Remarks:
- Deliquescent solid appearing as a viscous liquid.
- Details on test material:
- Storage: room temperature
Supplier: sponsor
batch/lot number: 209-653 (dried material from [Tradename] batch number 0001569403)
Expiry: December 3, 2021
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDermTM (EPI-200-MatTek Corporation)
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- Initially, the predictive capacity of the modified EpiDerm™ Skin Irritation Test (SIT) test method using MatTek EpiDermTM tissue model EPI-200 underwent full prospective validation from 2003-2007. The test method components of this method were used to define the essential test methods components of the original and updated ECVAM Performance Standards (PS). A modification of the original EpiDerm™ SIT was validated using the original ECVAM PS in 2008. In 2008, ESAC concluded that the Modified EpiDerm™ SIT has sufficient accuracy and reliability for prediction of R38 skin irritating and no-label (non-skin irritating) test substances.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The reconstructed human epidermal model EpiDermTM (EPI-200-MatTek Corporation) was used.
MatTek’s EpiDermTM model has been extensively characterised for multiple parameters including morphology, tissue viability, skin barrier function and sterility (for information see www.mattek.com). QC results for the specific lot of models received (Lot# 34130) were checked in-house for compliance with MatTek acceptance ranges with the following outcome (details in Annex 1):
• Morphology - PASS
• Tissue viability - PASS
• Skin barrier function (ET50 value for 1% Triton X-100) where ET50 is the time taken for 1% Triton X-100 to reduce the viability of the skin model to 50% relative to the negative control)- PASS
• Sterility testing showed no contamination during long term antibiotic and antimycotic free culture- PASS - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 30 µl of neat test item, negative control (DPBS) or positive control (SDS 5%)
- Duration of treatment / exposure:
- 60±1 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2, in humidified conditions)
- Duration of post-treatment incubation (if applicable):
- 42±4 hours post-treatment incubation, prior to the MTT endpoint; three tissues per condition (n=3).
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- relative to negative control
- Run / experiment:
- Run 1 (3 replicates) 60±1 minute exposure on the surface of the EpiDermTM reconstructed human epidermis, and a 42 ±4 hour post-exposure incubation time.
- Value:
- 46.604
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- All acceptance criteria indicated in the method section were passed
Any other information on results incl. tables
Table: Mean and SD of cell viability measurements and of viability percentages after 60±1 minutes of application and 42±4 hours post-incubation
Name | Code | Mean of OD | SD of OD | Mean of viability (%) | SD of viability (%) | CV % | Classification |
DPBS | NC | 1.674 | 0.032 | 100.000 | 1.900 | 1.900 | Non-Irritant |
SDS 5% | PC | 0.081 | 0.024 | 4.860 | 1.442 | 29.670 | Irritant |
N,N,N-trimethyl-3-{[(2E)-3-phenylprop-2-enoyl]amino}propan-1-aminium chloride | TA6 | 0.780 | 0.182 | 46.604 | 10.880 | 23.346 | Irritant |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- A test item is considered an irritant (I) to skin in accordance with UN GHS Category 2 if the skin model viability after exposure and post-treatment incubation is ≤50%.
- Conclusions:
- The percentage of viability obtained with the test item N,N,N-trimethyl-3-{[(2E)-3-phenylprop-2-enoyl]amino}propan-1-aminium chloride was 46.604%, therefore it was considered as Irritant to the skin.
- Executive summary:
In this study, the skin irritation potential of N,N,N-trimethyl-3-{[(2E)-3-phenylprop-2-enoyl]amino}propan-1-aminium chloride was assessed in vitro according to OECD Test Guideline 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method.
After 60±1 minute exposure on the surface of the EpiDermTM reconstructed human epidermis, and a 42 ±4 hour post-exposure incubation time, viability of the tissues was assessed and compared to the negative control.
The percentage of viability obtained was 46.604% and therefore: N,N,N-trimethyl-3-{[(2E)-3-phenylprop-2-enoyl]amino}propan-1-aminium chloride was classified as Irritant to the skin.
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